US20170081688A1 - Optimized method for decontaminating production of glucose polymers and glucose polymer hydrolyzates - Google Patents

Optimized method for decontaminating production of glucose polymers and glucose polymer hydrolyzates Download PDF

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US20170081688A1
US20170081688A1 US15/126,293 US201515126293A US2017081688A1 US 20170081688 A1 US20170081688 A1 US 20170081688A1 US 201515126293 A US201515126293 A US 201515126293A US 2017081688 A1 US2017081688 A1 US 2017081688A1
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activated carbon
porosity
glucose
treatment
hydrolyzates
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Pierre Lanos
Sophie Duvet
Thierry Dupont
Fabrice Allain
Mathieu Carpentier
Agnès Denys
Hèla Hacine-Gherbi
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Roquette Freres SA
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Roquette Freres SA
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Assigned to ROQUETTE FRERES reassignment ROQUETTE FRERES ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: DUPONT, THIERRY, DUVET, Sophie, LANOS, PIERRE, HACINE-GHERBI, Héla, ALLAIN, Fabrice, CARPENTIER, Mathieu, DENYS, Agnès
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    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12P—FERMENTATION OR ENZYME-USING PROCESSES TO SYNTHESISE A DESIRED CHEMICAL COMPOUND OR COMPOSITION OR TO SEPARATE OPTICAL ISOMERS FROM A RACEMIC MIXTURE
    • C12P19/00—Preparation of compounds containing saccharide radicals
    • C12P19/14—Preparation of compounds containing saccharide radicals produced by the action of a carbohydrase (EC 3.2.x), e.g. by alpha-amylase, e.g. by cellulase, hemicellulase
    • C—CHEMISTRY; METALLURGY
    • C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08B—POLYSACCHARIDES; DERIVATIVES THEREOF
    • C08B37/00—Preparation of polysaccharides not provided for in groups C08B1/00 - C08B35/00; Derivatives thereof
    • C08B37/0006—Homoglycans, i.e. polysaccharides having a main chain consisting of one single sugar, e.g. colominic acid
    • C08B37/0009—Homoglycans, i.e. polysaccharides having a main chain consisting of one single sugar, e.g. colominic acid alpha-D-Glucans, e.g. polydextrose, alternan, glycogen; (alpha-1,4)(alpha-1,6)-D-Glucans; (alpha-1,3)(alpha-1,4)-D-Glucans, e.g. isolichenan or nigeran; (alpha-1,4)-D-Glucans; (alpha-1,3)-D-Glucans, e.g. pseudonigeran; Derivatives thereof
    • C—CHEMISTRY; METALLURGY
    • C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08B—POLYSACCHARIDES; DERIVATIVES THEREOF
    • C08B37/00—Preparation of polysaccharides not provided for in groups C08B1/00 - C08B35/00; Derivatives thereof
    • C08B37/0006—Homoglycans, i.e. polysaccharides having a main chain consisting of one single sugar, e.g. colominic acid
    • C08B37/0024—Homoglycans, i.e. polysaccharides having a main chain consisting of one single sugar, e.g. colominic acid beta-D-Glucans; (beta-1,3)-D-Glucans, e.g. paramylon, coriolan, sclerotan, pachyman, callose, scleroglucan, schizophyllan, laminaran, lentinan or curdlan; (beta-1,6)-D-Glucans, e.g. pustulan; (beta-1,4)-D-Glucans; (beta-1,3)(beta-1,4)-D-Glucans, e.g. lichenan; Derivatives thereof
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Y—ENZYMES
    • C12Y302/00—Hydrolases acting on glycosyl compounds, i.e. glycosylases (3.2)
    • C12Y302/01—Glycosidases, i.e. enzymes hydrolysing O- and S-glycosyl compounds (3.2.1)
    • C12Y302/01078—Mannan endo-1,4-beta-mannosidase (3.2.1.78), i.e. endo-beta-mannanase
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/68—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids
    • G01N33/6863—Cytokines, i.e. immune system proteins modifying a biological response such as cell growth proliferation or differentiation, e.g. TNF, CNF, GM-CSF, lymphotoxin, MIF or their receptors

Definitions

  • the present invention relates to the development of an optimized method for decontaminating circuits for producing or purifying glucose polymers, more particularly those intended for the food (fiber-rich health ingredients) and medical (peritoneal dialysis) sectors, or glucose polymer hydrolyzates, more particularly those intended for the medical sectors (apyrogenic injectable glucose).
  • the Applicant company has chosen to develop its invention in afield which is known for the dangerousness of the contaminants of microbial origin capable of developing in circuits for producing glucose polymers or in those for producing hydrolyzates thereof, said contaminants being the source of possible:
  • Peritoneal dialysis is in fact a type of dialysis, the aim of which is to remove waste such as urea, creatinine, excess potassium or surplus water that the kidneys cannot manage or can no longer manage to purify out of the blood plasma. This medical treatment is indicated in the event of end-stage chronic renal failure.
  • dialyzates most commonly used are composed of a buffer solution (of lactate or of bicarbonate) at acidic pH (5.2-5.5) or physiological pH (7.4) to which are added:
  • European patent application EP 207 676 teaches that glucose polymers forming clear and colorless solutions at 10% in water, having a weight-average molecular weight (Mw) of 5 000 to 100 000 daltons and a number-average molecular weight (Mn) of less than 8 000 daltons, are preferred.
  • Mw weight-average molecular weight
  • Mn number-average molecular weight
  • Such glucose polymers also preferably comprise at least 80% of glucose polymers of which the molecular weight is between 5 000 and 50 000 daltons, little or no glucose or glucose polymers with a DP less than or equal to 3 (molecular weight 504) and little or no glucose polymers with a molecular weight greater than 100 000 (DP of about 600).
  • the preferred glucose polymers are glucose polymers with a low polydispersity index (value obtained by calculating the Mw/Mn ratio).
  • the glucose polymer obtained by chromatographic fractionation then preferably contains less than 3% of glucose and of glucose polymers having a DP less than or equal to 3 and less than 0.5% of glucose polymers having a DP greater than 600.
  • glucose polymer production circuits can be contaminated with microorganisms, or with pro-inflammatory substances contained in said microorganisms.
  • the contamination of corn or wheat starches with microorganisms of yeast, mold and bacteria type, and more particularly with acidothermophilic bacteria of Alicyclobacillus acidocaidarius type (extremophilic bacteria which grow in the hot and acidic zones of the circuit) is, for example, described in the starch industry.
  • Stepper peritonitis which is described as aseptic, chemical or culture-negative peritonitis, is, for its part, typically caused by a chemical irritant or a foreign body.
  • LPSs Lipopolysaccharides
  • PPNs peptidoglycans
  • formylated microbial peptides In addition to the PGN depolymerization products, formylated microbial peptides, the prototype of which is f-MLP (formyl-Met-Leu-Phe tripeptide), also have a substantial synergistic activity. Originally, these peptides were identified for their chemoattractant activity on leukocytes, although they are incapable of inducing a cytokine response per se.
  • the Applicant company has therefore devoted itself to developing detection and assaying methods which are more effective than those accessible in the prior art.
  • monocyte cell lines give consistent responses, thereby explaining why the tests currently being developed increasingly use cells of this type in culture.
  • these tests have the drawback of giving an overall inflammatory response to all the contaminants present as a mixture in a solution, and consequently do not make it possible to characterize the nature of the contaminant.
  • cytokines of the acute phase of the inflammation such as:
  • the Applicant company then sought to better define the key purification steps to be carried out to ensure optimum safety for the production lines, especially those for glucose polymers.
  • the present invention therefore proposes a combination of several decontamination steps carefully selected and placed in order, which proves effective in eliminating all the inflammatory molecules that may be present in the production circuits, especially glucose polymers, irrespective of the nature of the contamination.
  • the method of the invention thus relates to the following combination of steps;
  • the method comprises the 5 steps.
  • the glucose polymers are selected from icodextrin and maltodextrins, in particular branched or unbranched maltodextrins, and the glucose polymer hydrolyzates are a product of total hydrolysis, such as dextrose monohydrate,
  • the method of the invention is intended to replace the routes conventionally used to purify glucose polymers or the hydrolyzates thereof.
  • the method for decontaminating glucose polymers or the hydrolyzates thereo in accordance with the invention comprises the following steps:
  • the glucose polymers or the hydrolyzates thereof may be intended for peritoneal dialysis, enteral and parenteral feeding and the feeding of neonates.
  • the glucose polymers which will be prepared within the context of the present invention are icodextrin or maltodextrins (which are branched or unbranched, as will be described below).
  • the glucose polymer hydrolyzates concerned here are understood to be, especially, the product of total hydrolysis, such as apyrogenic dextrose monohydrate, sold under the trade name LYCADEX® PF by the Applicant company.
  • They may be decontaminated at one or several stages of their preparation, and especially at the latter steps of their preparation method.
  • glucose polymers or the hydrolyzates thereof provided in the methods according to the present invention correspond to the product preceding the final product.
  • the pro-inflammatory components are above all molecules of bacterial origin.
  • They may be, in particular;
  • the methods for measuring the in vitro inflammatory responses which are used in the context of the present invention to monitor the effectiveness of the decontamination steps of the methods for preparing glucose polymers for therapeutic use in humans (e.g. peritoneal dialysis solutions) are based on cell tests (“bio-assays”) using lines of monocyte/macrophage type (THP-1, and/or Raw-BlueTM) and transfected lines expressing a specific natural immunity receptor (HEK-BlueTM), which cell tests were developed by the Applicant company and detailed in its prior patent applications.
  • bio-assays using lines of monocyte/macrophage type (THP-1, and/or Raw-BlueTM) and transfected lines expressing a specific natural immunity receptor (HEK-BlueTM), which cell tests were developed by the Applicant company and detailed in its prior patent applications.
  • the cell lines are used at a density between 0.5 and 1 ⁇ 10 6 cells/ml of culture medium, and the bringing of the preparation of glucose polymers or hydrolyzates thereof into contact with the cells lasts approximately 16 to 24 h.
  • Quantification of the contaminants may be carried out using a dose-response curve.
  • This dose-response curve may especially be produced with the same cells, under the same conditions, with increasing doses of contaminants.
  • the dose-response curves are in particular produced with LPS, PGN, lipopeptide and MDP standards.
  • such a dose-response curve can be produced for cells expressing TLR4 (for example, THP-1, HEK-BlueTM hTLR4 and Raw-BlueTM) with increasing doses of LPS, for cells expressing TLR2 (for example, THP-1. HEKBlueTM hTLR2 and Raw-BlueTM) with increasing doses of PGN, and for cells that are reactive via NOD2 (for example, HEK-BlueTM hNOD2) with increasing doses of MDP.
  • TLR4 for example, THP-1, HEK-BlueTM hTLR4 and Raw-BlueTM
  • TLR2 for example, THP-1. HEKBlueTM hTLR2 and Raw-BlueTM
  • NOD2 for example, HEK-BlueTM hNOD2
  • the cell tests may be carried out as described in the Applicant's patent applications: WO2012/143647 and WO2013/178931.
  • the first decontamination step of the method in accordance with the invention consists of a treatment by an enzymatic preparation with detergent and clarifying properties.
  • mannanase type such as the enzymatic preparation Mannaway® sold by Novozymes, has proven effective for dissociating macrocomplexes such as bacterial debris and high molecular weight PGNs.
  • the solution is neutralized by HCl and the enzyme is inactivated by heating at 85° C. for 10 mins,
  • the second step consists of a treatment by a pharmaceutical-grade activated carbon with very high adsorption capacity and “microporous” porosity.
  • the Applicant company recommends using an activated carbon of Norit C Extra USP type, This is because C Extra USP carbon proves effective in eliminating PGNs and their degradation products.
  • the third step consists of a treatment by a second activated carbon with “mesoporous” porosity. This step is optional,
  • an activated carbon of ENO-PC type is preferred.
  • This quality of activated carbon has a broad spectrum of action and makes it possible preferentially to eliminate molecules with a molecular weight of ⁇ 100 kDa (for example, LPS and degradation products of PGNs).
  • the fourth step consists of a treatment on a macroporous adsorbent polymer resin having a porosity of greater than 100 angstrom.
  • Dowex SD2 resin is chosen, which has a broader spectrum of elimination of contaminating molecules (other than PGNs) than other resins of the same family.
  • the 32% (250 ml) glucose polymer solutions are eluted on a column containing 20 ml of this resin.
  • the final step consists of filtration on an ultrafiltration membrane having a cut-off threshold of 5 kDa.
  • the aim of the treatment by ultrafiltration is to eliminate the molecules of small size that are still present in the glucose polymer solutions.
  • the Applicant company recommends using this treatment at the end of the method, since this treatment also has a dialysis effect which makes it possible to eliminate traces of salts which have accumulated over the course of the preceding treatments.
  • the retentate is injected into the starting solution and continually adjusted to the initial volume (100 ml) by addition of sterile PBS buffer. After 3 h, the volume of filtrate is between 150 and 200 ml, which is greater than the initial volume of the glucose polymer solution.
  • this combination of steps alone is able to provide maximum protection for the circuits for producing polymers and glucose and derivatives thereof from contaminants of bacterial origin.
  • the dose-response curves are produced with standard agonist molecules: LPS, PGN, PAM3(cys) (PAM 3 Cys-Ser-(Lys)4 trihydrochloride, a synthetic lipopeptide), LTA, zymosan and MDP.
  • LPS standard agonist molecules
  • PGN PAM3(cys) (PAM 3 Cys-Ser-(Lys)4 trihydrochloride, a synthetic lipopeptide)
  • LTA lipopeptide
  • zymosan zymosan
  • MDP standard agonist molecules
  • the Raw-BlueTM and HEK-BlueTM hTLR2, hTLR4, hNOD2 and Null lines are incubated with increasing concentrations of agonists, and the cell response is measured by quantifying the SEAP activity, TNF- ⁇ is used as positive control for cell activation:
  • the matrices are as follows:
  • the aim of these tests is to determine the pro-inflammatory reactivity and the nature of the contaminants present in the various matrices.
  • the samples according to example 2 are prepared at 32% (weight/volume) in non-pyrogenic water (for injection).
  • the samples are diluted to 1/10 in the cell culture medium (final concentration: 3.2% (w/v)).
  • the Applicant company has chosen to use the activated carbons alone or combined in pairs in the various combinations, and given that the treatments by carbons are carried out batchwise and require heating, neutralization and filtration steps, they are carried out just after the enzymatic treatment but before the other treatments.
  • the aim of the treatment by 5 kDa ultrafiltration is to eliminate the molecules of small size that are still present in the glucose polymer solutions.
  • this procedure has a dialysis effect and makes it possible to eliminate traces of salt that have accumulated over the course of the previous treatments.
  • This step is therefore systematically placed at the end of the procedure.
  • samples are taken under sterile conditions and are used in the cell tests, so as to assay the overall inflammatory load (Raw-BlueTM cell response) and the amounts of biocontaminants (HEK-BlueTM responses).
  • the cell responses obtained after each step are compared to the response induced by the starting matrix, so as to estimate the effectiveness of the decontamination procedures, The results are expressed as activity relative to the maximum cell response.
  • a non-contamination control is carried out with a solution of P11-11 icodextrin.
  • the E1242 matrix induces an intermediate inflammatory response in the Raw-Blue cells, which is predominantly linked to a high concentration of PGN (TLR2 response),
  • the other steps do not have an effect on the TLR2 response, which does not evolve any more up to the end of the procedure.
  • the TLR4 response is no longer detectable as early as at the 1 st treatment step, which proves that the LPSs have been eliminated.
  • the NOD2 response this is suppressed after the ultrafiltration step.
  • procedure 1 is insufficient to ensure complete decontamination of a matrix heavily loaded with PGNs.
  • TLR2 response is still higher than the non-contamination control, which indicates that traces of PGN are still present.
  • the difference in the responses is certainly linked to the fact that the HEK-TLR2 cells have a lower detection threshold for PGNs than the Raw-Blue cells.
  • the NOD2 response is reduced after passage over SD2 and suppressed after ultrafiltration, which suggests that this resin has an at least complementary action to eliminate the degradation products of PGNs.
  • a SUPRA EUR carbon preferentially eliminates molecules of high molecular weight.
  • This combination should be effective for decontaminating samples loaded with aggregated macrocomplexes of PGN or ⁇ -glucan type.
  • the responses of the Raw cells and the HEK-TLR2 cells have decreased significantly but remain above the negative control.
  • the TLR4 and NOD2 responses remain large, and it is necessary to await the passage over the resin and the final step of ultrafiltration to obtain a signal identical to the non-contamination control in the various cell types.
  • a step of enzymatic treatment by Mannaway® is introduced upstream of the other steps.
  • the combination of enzyme+carbon treatments is particularly suited to eliminating PGNs, since the TLR2 response goes from a saturated signal before treatment to a signal identical to the non-contamination control.
  • E1565 matrix which is contaminated with the various agonists of TLR2, TLR4 and NOD2.
  • the response of the Raw-Blue cells has decreased significantly, but remains slightly greater than the non-contamination control. This very weak response is not linked to the presence of residual PGN but rather to traces of LPS and of NOD2 agonists, and to a possible synergistic effect between the two families of molecules.
  • the ENO-PC carbon has a broad spectrum of retention for molecules of molecular weight ⁇ 100 kDa (LPS and degradation products of PGNs),
  • the combination comprises the following steps:
  • FIG. 1 Responses of the Raw-BlueTM cells to standard agonists.
  • FIG. 2 Responses of the HEK-BlueTM TLR2 cells to standard agonists
  • FIG. 3 Responses of the HEK-BlueTM TLR4 cells to standard agonists.
  • FIG. 4 Responses of the HEK-BlueTM NOD2 cells to standard agonists.
  • FIG. 5 Responses of the HEK-BlueTM Null cells to standard agonists.
  • FIG. 6 Cell responses induced by the glucose polymer matrices.
  • FIG. 7 Cell responses induced by the E1242 matrix after decontamination according to procedure 1.
  • FIG. 8 Cell responses induced by the E209J matrix after decontamination according to procedure 2.
  • FIG. 9 Cell responses induced by the E5248 matrix after decontamination according to procedure 5.
  • FIG. 10 Cell responses induced by the E3063 matrix after decontamination according to procedure 3.
  • FIG. 11 Cell responses induced by the E1565 matrix after decontamination according to procedure 4.

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US15/126,293 2014-03-21 2015-03-20 Optimized method for decontaminating production of glucose polymers and glucose polymer hydrolyzates Abandoned US20170081688A1 (en)

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FR1452354 2014-03-21
FR1452354 2014-03-21
PCT/FR2015/050706 WO2015140477A1 (fr) 2014-03-21 2015-03-20 Procede optimise de decontamination de production de polymeres de glucose et d'hydrolysats de polymeres de glucose

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US20180148754A1 (en) * 2015-06-04 2018-05-31 Roquette Freres Optimised method for decontaminating the starch used as a raw material for obtaining glucose polymers intended for peritoneal dialysis

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US20230279455A1 (en) 2023-09-07
JP6284651B2 (ja) 2018-02-28
ES2941274T3 (es) 2023-05-19
US20200308614A1 (en) 2020-10-01
EP3119813A1 (fr) 2017-01-25
CN106068279B (zh) 2018-11-09
PL3119813T3 (pl) 2023-05-08
CA2940566A1 (fr) 2015-09-24
JP2017510674A (ja) 2017-04-13
EP3119813B1 (fr) 2023-01-04
WO2015140477A1 (fr) 2015-09-24
CA2940566C (fr) 2022-11-22
MX2016011365A (es) 2017-10-02
CN106068279A (zh) 2016-11-02

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